Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06532084

Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen

Led by St. Petersburg State Pavlov Medical University · Updated on 2024-08-01

88

Participants Needed

1

Research Sites

205 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a single-center randomized open-label phase II clinical trial to compare relapse prophylaxis with sorafenib and observation after graft-versus-host disease prophylaxis with post-transplantation bendamustine and cyclophosphamide in high-risk myeloid malignancies. This is an intention to treat study, where randomization is performed at first documentation of CR after engraftment.

CONDITIONS

Official Title

Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must undergo allogeneic hematopoietic stem cell transplantation with post-transplant bendamustine and cyclophosphamide from any donor.
  • Patients must have high-risk myeloid malignancy defined as refractory AML, third or higher remission of AML, myeloid malignancy with bi-allelic tp53 mutation, complex karyotype, therapy-related myeloid malignancy not in MRD-negative response, very high IPSS-R risk MDS, myeloid malignancy with monosomal or t(3;3) karyotype, or with ASXL1, bi-allelic tp53, RUNX1 mutation, or EVI1 overexpression.
  • Patients must have documented hematological remission in bone marrow at inclusion post-engraftment; measurable residual disease is allowed.
  • Inclusion must be within first 100 days after allogeneic hematopoietic stem cell transplantation.
Not Eligible

You will not qualify if you...

  • Successfully treated relapse between transplantation and enrollment.
  • Use of any other planned method for relapse prophylaxis besides sorafenib.
  • Donor lymphocyte infusion prior to randomization.
  • Second malignancy not in complete remission within 6 months prior to randomization.
  • Moderate or severe cardiac disease including ejection fraction less than 50%, unstable or severe angina, chronic heart failure NYHA class III or IV, Lawn grade V arrhythmia, or recent myocardial infarction within 3 months.
  • Stroke within 3 months unless related to underlying malignancy.
  • Severe pulmonary dysfunction with FEV1 or DLCO below 50%, respiratory distress, or need for oxygen support.
  • Severe organ dysfunction with AST or ALT over 10 times normal, bilirubin over 2 times normal, or creatinine over 2 times normal.
  • Creatinine clearance less than 30 mL/min.
  • Uncontrolled bacterial or fungal infection at enrollment defined by CRP over 70 mg/L.
  • Requirement for vasopressor or positive-pressure oxygen support at enrollment.
  • Karnofsky index less than 30%.
  • Pregnancy.
  • Somatic or psychiatric disorder preventing informed consent.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

RM Gorbacheva Research Institute

Saint Petersburg, Russia, 197022

Actively Recruiting

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Research Team

I

IVAN S MOISEEV

CONTACT

I

Irina V Bykova

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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